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Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

This study has been terminated.
(This was a follow-on study to Biomed 777-CLP-029 which did not meet superiority endpoint)
Sponsor:
Information provided by:
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT00267553
First received: December 20, 2005
Last updated: September 7, 2007
Last verified: September 2007
  Purpose

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.


Condition Intervention Phase
Breast Neoplasms
Neoplasms, Hormone-Dependent
Drug: Atamestane
Drug: toremifene
Drug: letrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm

Secondary Outcome Measures:
  • In conjunction with the data from Biomed 777-CLP-29, obtain safety, survival and time to treatment failure (TTF) data for both arms in this continuation study.

Estimated Enrollment: 200
Study Start Date: November 2005
Study Completion Date: June 2006
Detailed Description:

Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve complete suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the survival time for subjects with advanced breast cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last Biomed 777-CLP-29 visit
  • To continue on survival follow-up, subjects must be in survival follow-up in study Biomed 777-CLP-29
  • Written informed consent obtained for subjects who continue study drug treatment

Exclusion Criteria:

  • Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason
  • Subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267553

  Show 35 Study Locations
Sponsors and Collaborators
Intarcia Therapeutics
Investigators
Study Director: Peter Langecker, MD, PhD Intarcia Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00267553     History of Changes
Other Study ID Numbers: Biomed 777-CLP-32
Study First Received: December 20, 2005
Last Updated: September 7, 2007
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Keywords provided by Intarcia Therapeutics:
Atamestane
Breast neoplasms
Combined hormonal therapy
Complete estrogen blockade
Ductal breast carcinoma
Estrogen blocker
Fareston®
Femara®
First line therapy
Letrozole
Lobular breast carcinoma
Locally advanced breast cancer
Locally recurrent breast cancer
Maximal estrogen inhibition
Metastatic breast cancer
Neoplasms, Hormone-dependent
Receptor-positive
Stage IIIA breast cancer
Stage IIIB breast cancer
Stage IV breast cancer
Toremifene

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms, Hormone-Dependent
Breast Diseases
Neoplasms by Site
Skin Diseases
Atamestane
Letrozole
Toremifene
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014